ANZCTR search results

The Bridging Study aims to evaluate, implement and upscale the Navicare model of care. In the Navicare model of care, a Care Navigator links help seekers with supports they may need to improve their mental wellbeing. The Care Navigator assists with referrals, makes appointments with mental health care professionals, and provides a private space in which to access online mental health support from online psychology and other service providers. The Navicare model currently exists in the town of Moranbah (“Hub 1”), in the Bowen Basin region of Queensland. The Bridging Study will evaluate Navicare in three new sites. The study hypothesises that implementation of Navicare, using a locally tailored approach that addresses barriers to implementation supported by evidence-informed implementation strategies, will sustain access (primary outcome) to mental health services in regional settings in the post-implementation period compared to the implementation and pre-implementation period. It also hypothesises that sites that engage more with Navicare will be more successful in sustaining improved access and uptake of mental health services, and reducing crisis mental-health-related Emergency Department (ED) presentations, mental-health related time in Emergency Departments, and overnight hospitalisations compared to the implementation and pre-implementation periods; and will improve access and uptake of mental health services in the implementation period compared to the pre-implementation period.

This project seeks to undertake a prospective longitudinal natural history study to generate a comprehensive phenotypic profile of biological, behavioural, clinical, neurocognitive and neurophysiological markers associated with INDD and its progression; and correlate with the genotype when clinically available. This work will provide more complete neurobiological descriptions, novel mechanistic insights, and clear recommendations regarding candidate biomarkers for diagnosis and treatment tracking.

We will conduct a multi-centred, double-blind randomised sham-controlled trial on 88 people with chronic SCI. The primary outcome will be walking ability measured using the Two Minute Walk Test (2MWT) with stimulation. Participants will be randomised to either the Stimulation group or the Sham group. All participants will receive the same intensive locomotor training consisting of three thirty minute sessions per week, over 12 weeks, in combination with either stimulation or sham stimulation. The secondary outcomes will capture different aspects of recovery, strength, spasticity, and quality of life. Outcome measures will be taken at baseline, Day 0, 13-weeks and 6-months after randomisation. Our hypothesis is that spinal stimulation plus locomotor training in chronic SCI will improve walking ability, demonstrated by a clinically important change on the 2 Minute Walk test and that spinal stimulation will be a feasible and safe treatment that can be provided in a community setting.

In this randomised, double-blind, placebo-controlled study, 100 young-to-middle-aged adults aged 18 to 45 years with self-reported sleep difficulties will be randomly assigned to receive magnesium L-threonate (Magtein) or a placebo for 6 weeks. Changes in cognitive performance will be assessed at baseline and week 6 by administering The National Institutes of Health (NIH) Toolbox Cognition Battery and Raven’s Progressive Matrices Second Edition (Raven’s 2). Moreover, self-report questionnaires will be administered to examine changes in sleep quality, restorative sleep, and general wellbeing. Changes in sleep patterns will also be monitored using an Oura Ring. Finally, to measure potential changes in gaming skills, the 3D Aim Trainer, a first-person shooting game, will be administered at baseline and week 6.

The current study will investigate the effect of meal time alteration on the quality of sleep, separately in early birds, night owls, and intermediate chronotypes. We hypothesize that taking the evening meal closer to bedtime reduces sleep quality in morning people, but not in night owls.

Bile acids, released into the intestine after the meals, have long been regarded as simple ‘intestinal detergents’ to aid fat digestion. Recent evidence suggests that bile acids are also capable of regulating the blood sugar levels after meals, by releasing of a hormone from the intestines called glucagon-like peptide-1 (GLP-1). We recently showed that a bitter tasting substance, denatonium benzoate, could enhance the release of GLP-1. We now want to test whether combining a bile acid (taurocholic acid) with denatonium benzoate in capsules taken by mouth will improve blood glucose control after a meal in people with type 2 diabetes.

This study aims to explore the efficacy of in-person and online MBSR for improving mental health and metabolic profile in diabetes patients living in regional and rural north Queensland using a RCT design. Our study will answer three research questions: 1) Is in-person MBSR efficacious for improving mental health and metabolic profile in diabetes patients? 2) Is online MBSR efficacious for improving mental health and metabolic profile in diabetes patients? 3) Are mental health benefits observed after 4- and 6-week interventions?

This is a first-in-human, single-centre, randomised, double blind, three-part single and multiple ascending dose study to assess the safety and tolerability of OXT-328 and how this drug acts in the body in healthy volunteers. Who is it for? You may be eligible for this study if you are aged 18 to 65 years and are in good general health without a clinically significant medical history. Study details: All healthy volunteer participants who choose to enrol in this study will be assigned by chance to receive either a single or multiple doses of OXT-328 or placebo. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood and urine samples for testing. The data generated in this study will inform the design of future clinical studies and to select the dose(s) for future studies in patients with CIPN.

The REAL study is a pilot randomised, placebo-controlled clinical trial investigating the effects of green rooibos tea extract supplementation (dose = 500mg of rooibos extract) on anxiety levels in mildly to moderately anxious adults. The study incorporates a one week baseline period, 8-week intervention period and 2-week follow up.

A sudden worsening of respiratory symptoms in Chronic obstructive Pulmonary Disease (COPD) is called a flare up. These flare ups are caused by respiratory infections. Exercise programs can reduce the number of people experiencing a flare up of COPD by as much as 40%. We don’t yet know why this happens. Key reasons why people with COPD have flare ups include weakened body defences (immune system) against respiratory infections. Measuring responses to safe, but foreign substances like vaccines provide one of the best ways to test how well the immune system defends against infections. We intend to find out if it is possible to use the flu or COVID-19 booster vaccines to understand how exercise changes the immune system of people with COPD. The project will recruit 45 volunteers with COPD. The project will split the volunteers into 3 groups: 1) 8 week exercise program before receiving a flu or COVID-19 vaccine; 2) 8 week exercise program before receiving a flu or COVID-19 vaccine and a single exercise session immediately after vaccination; 3) no exercise before or after flu or COVID-19 vaccine. We will collect blood and saliva from volunteers at the start of the project, before vaccination and on three occasions after vaccination.